Biotech Stocks Facing FDA Decision In November

As another month comes to a close, it's time to take a look back at some of the pharma news stories of October, and look ahead at what's coming next over the horizon on the regulatory front.

Bose Hearing Aid, the first self-fitting hearing aid controlled by the user, was greenlighted on October 5. This approval gives individuals 18 years or older with perceived mild to moderate hearing loss access to a new hearing aid that provides them with direct control over the fit and functionality of the device.

A diagnostic test, by the name PicoAMH, to aid in the determination of menopausal status, developed by Ansh Labs, won FDA approval on October 24. This test, when used in conjunction with other clinical assessments and laboratory findings, can help inform discussions about preventative care, such as ways to help prevent loss in bone mineral density or to address cardiovascular disease, both of which are known to increase after menopause, according to Courtney Lias, director of the Division of Chemistry and Toxicology Devices in the FDA's Center for Devices and Radiological Health.

In a bid to crack down on websites selling illegal, potentially dangerous drugs claiming to treat cancer and HIV, the FDA launched a global operation in partnership with international regulatory and law enforcement agencies on October 23. The effort, led by Interpol, was part of Operation Pangea XI, the eleventh annual International Internet Week of Action (IIWA).

On October 24, the Substance Use-Disorder Prevention that Promotes Opioid Recovery and Treatment (SUPPORT) for Patients and Communities Act was signed into law by President Trump, building on the progress made in addressing the devastating opioid crisis.

The same day, October 24, the FDA approved a new drug, Xofluza, to treat influenza, which marked the first new antiviral flu treatment with a novel mechanism of action approved in the U.S. in nearly 20 years.

With still two more months for the year to end, the number of *novel drug approvals has already reached 47 for this year. In 2017, 46 novel drugs were approved by the FDA, which was more than double the number approved in 2016 and the highest in 21 years. (*Novel drugs are new molecular entities (NMEs) having chemical structures that have never been approved before).